Policies and the Human Research Protection Program Manual
The Human Research Protection Program Manual
Section 1 Wayne State University Human Research Policy
1-2 Wayne State University Human Research Protection Program
1-3 Wayne State University Human Protection Program: Roles and Responsibilities
1-4 What is Human Participant Research?
Section 2 Ethical Principles
Section 3 WSU Affiliate Contracts and Agreements
3-3 John D. Dingell Veterans Administration Medical Center Memo of Understanding
Institutional Review Board Policies and Procedures
Section 4 Protocol Review
4-2 Initial Protocol Submission Requirements
4-3 Unexpected Problems (Also refer to Section 13)
4-5 Expedited Review Procedures
4-6 Amendments to the Research Protocols and Informed Consent (03/2012)
4-7 Continuation/Renewal of Protocol
4-8 Closure of a Research Protocol (03/2013)
4-9 Determining Projects that Require Additional Verification
4-10 Criteria for Determining Frequency of Review (02/2012)
4-11 Outcomes of Proposal Reviews by the Institutional Review Board
4-12 Notification of IRB Decisions to Principal Investigator and PI Response
4-13 Conditional Approvals and Subsequent Decisions by IRB Chairs
4-14 General Counsel: Roles and Responsibilities
4-15 Document Retention for Research Protocols
4-16 Quality Improvement Program
Section 5 Institutional Review Board
5-1 Expectations of IRB Membership
5-2 Selection and Review of Institutional Review Board Members and Staff
5-3 Policy and Procedure Development and Approval
5-4 Selection of Alternative IRB Member for Duly Constituted Meeting (02/2012)
5-5 Minutes Requirements (07/2012)
Section 6 Principal Investigator
6-1 Principal Investigator: Roles and Responsibilities
6-2 Investigator Initiated Research
6-6 Department of Defense Requirements for Human Subject Research Protection
Section 7 Recruitment and Participant Rights
7-1 Recruitment of Research Participants
7-2 The Inclusion of Pregnant Women in Research
7-3 The Inclusion of Women and Minorities in Research
7-6 Costs Associated with Research Participation
7-7 Compensation for Research Participation
Section 8 Research Involving Vulnerable Participants
8-1 Research Involving Fetuses and Neonates
8-2 Vulnerable Participants: Children (07/2012)
8-3 Vulnerable Participants: Cognitively Impaired and Mentally Disabled
8-4 Vulnerable Participants: Prisoners
8-5 Vulnerable Participants: Terminally Ill
8-6 Vulnerable Participants: Normal Volunteers
8-7 Vulnerable Participants: Students, Trainees and Employees
Section 9 Informed Consent
9-2 Informed Consent Involving Non-English Speaking Participants
9-4 Obtaining Permission from Legally Authorized Representatives or Family Members
Section 10 HIPAA
10-1 HIPAA Requirements in Research
Section 11 Research Involving Drugs and Devices
11-1 Investigational Drug Research
11-2 Approved and Unapproved Devices in Research
11-3 Emergency Single Time Use of a Test Article (Drug, Biologic, Device)
11-5 Off Label Use of Drugs and Devices
11-6 Planned Emergency Research
11-7 Compassionate and Expanded Use of Drugs and Devices
Section 12 Research Procedures
12-1 The Use of Biological Specimens in Research
12-2 Data Safety and Monitoring in Research
12-3 Research Studies Involving the Collection of Blood Samples
Section 13 Reporting Responsibility
13-1 Unexpected Problems (04/2013)
13-2 Reporting Unexpected Problems
13-4 Determining which Adverse Events are Unexpected
Section 14 Conflict of Interest
14-1 Conflict of Interest: Principal Investigator/Key Personnel
14-2 Conflict of Interest: Institutional Review Board Members and IRB Administration Staff
Section 15 Non-Compliance
15-1 Identifying, Defining and Managing Non-Compliance in Human Research
15-3 Suspension and Termination of Research Protocols
Section 16 References
16-4 Dingell Veterans Administration Policy
16-8 Department of Defense (DoD)
16-9 Department of Energy (DoE)
16-11 Environmental Protection Agency (EPA)
Contact Information
IRB Administration Office
87 E. Canfield, Second Floor
Detroit , MI 48201
(313) 577-1628
Associate Director of IRB Administration (313) 993-7155
Education Coordinator (313) 577-9534
Division of Research, Office of Research Compliance (313) 577-9064